Gedeon Richter and Bio-Thera Solutions have announced a European licensing deal worth potentially more than $100m for the Chinese biosimilar developer’s BAT2206 proposed rival to Stelara.
With the UK generics market facing a rising number of supply issues, local off-patent industry association the BGMA has put forward a raft of policy proposals that it said could provide solutions.
Alvotech is the latest to join several other competitors who have already submitted their denosumab biosimilar marketing authorization applications to the EMA.
The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.
Teva has resolved a pair of civil US Department of Justice lawsuits accusing the firm of violating the US Anti-Kickback Statute and the False Claims Act through its alleged conduct conspiring to fix the price of three generic drugs and for allegedly paying Medicare patients’ copays for its multiple sclerosis brand Copaxone.
In the space of a few days, all four generics manufacturers that had successfully petitioned for a re-examination of a key patent shielding Novo Nordisk’s mega blockbuster Ozempic have reached settlement agreements terminating their challenges.
Lupin has added two ADHD drugs to its Canadian portfolio, while also signing multiple branded deals in other global markets.
Hyloris recognized that the suspension of its shares as part of a broader business fallout has “created uncertainty and temporarily impacted management and organizational focus,” as it got another commercial deal over the line for its Maxigesic IV (paracetamol/ibuprofen) solution for infusion.
Sandoz, Adalvo and Eurofarma were the biggest winners at the Global Generics & Biosimilars Awards 2024, each taking multiple honors, among the many champions named across 14 separate categories at our prizegiving ceremony in Milan.
The US FTC and FDA both received letters from the Senate but with different messaging. One commends for achieved findings and requests a new investigation and another scalds for not doing the assigned job.
Teva has broken new ground by filing its first independent biosimilar to the US Food and Drug Administration, for a proposed biosimilar to Amgen’s Prolia treatment for osteoporosis in postmenopausal women. However, the Israeli firm made no mention of its proposed Xgeva biosimilar, which it states is in Phase III clinical trials.
Gilead strikes voluntary licensing agreements with six generic manufacturers for lenacapavir but health groups seek clarity on pricing and seeming API supply restrictions. All eyes are also on the patent opposition case in India.
The world’s best-selling diabetes medicine, with sales last year across the globe of around $14bn, is now in the crosshairs in the US for Viatris’ Mylan and its partner Natco, after the firms announced an agreement settling litigation that was pending before the US Patent and Trademark Office’s Patent Trial and Appeal Board.
Japan has started to charge patients a portion of the difference between the reimbursement price of the generic and non-generic product if they insist on the latter without a supporting recommendation from the prescribing physician, in a policy designed to further drive generic use.
Biocon Biologics chief commercial officer for advanced markets Matt Erick says the firm is a “quiet giant” in the biosimilars space, but speaks up about the firm’s plans to grow its business in Europe, explore in-licensing as well as in-house development, and capitalize on the upcoming loss of exclusivity for Stelara in the US.
Aspire Pharma has bolstered its dermatology portfolio by striking a deal to acquire “all assets” of another UK-based player, Canute Pharma.
Alkem and Torrent said the tested batches were not manufactured by them, as a recent CDSCO report pinned their drugs as “not of standard quality”. Meanwhile, other firms informed the agency themselves about counterfeit drugs on the market.
Teva is continuing along its well-trodden path of partnered biosimilar assets, striking a further agreement with Spanish develop mAbxience that could be for the development of either pembrolizumab or nivolumab.
A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
As Sandoz publishes a report on US drug shortages – dissecting their root causes, the current policy landscape and recommendations for future improvements – the firm’s North America head and AAM chair Keren Haruvi speaks to Generics Bulletin about what can be done to alleviate continuing supply-chain failures.